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AstraZeneca's Ultomiris Meets Goal in Rare Kidney Disease Study
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Key Takeaways
AstraZeneca's Ultomiris met the first primary endpoint in the late-stage I CAN IgAN study.
Ultomiris cut proteinuria significantly by week 34, with effects seen as early as week 10.
AZN plans accelerated filings; drug posted $4.72B sales in 2025, up 20% year over year.
AstraZeneca (AZN - Free Report) announced positive results from an interim analysis of the ongoing late-stage I CAN study, which evaluated its blockbuster rare disease drug Ultomiris (ravulizumab) for IgA nephropathy (IgAN), a rare progressive kidney disease.
At the interim analysis, the study met its first primary endpoint. Treatment with Ultomiris for 34 weeks led to a statistically significant and clinically meaningful reduction in proteinuria (protein in urine), with effects observed as early as week 10.
While AstraZeneca did not disclose numerical data, it plans to share the results with regulatory authorities to pursue accelerated approval across key markets. The I CAN study will continue toward completion, with the second primary endpoint — change in estimated glomerular filtration rate (eGFR) — to be evaluated at week 106.
Ultomiris is currently approved in the United States, Europe and Japan across four indications. These include atypical haemolytic uraemic syndrome (aHUS), generalized myasthenia gravis (gMG), neuromyelitis optica spectrum disorder ("NMOSD") and paroxysmal nocturnal haemoglobinuria ("PNH").
The drug has become a key driver of growth for the company. In 2025, Ultomiris generated $4.72 billion in sales, up 20% year over year, driven by strong demand across approved indications, geographic expansion and continued patient conversion from Soliris.
AZN Stock Performance
The stock outperformed the industry in the year-to-date period, as seen in the chart below.
Image Source: Zacks Investment Research
Other Players in the IgAN Space
If approved, Ultomiris will likely compete with the likes of Calliditas Therapeutics’ Tarpeyo, Novartis’ (NVS - Free Report) Fabhalta and Travere Therapeutics’ (TVTX - Free Report) Filspari.
Both Calliditas’ Tarpeyo and Travere’s Filspari are approved for a similar indication — to slow the decline in kidney function in adults with primary IgAN who are at risk of disease progression.
Novartis’ Fabhalta is approved under the accelerated pathway for reducing proteinuria in adults with primary IgAN at risk of rapid disease progression. The NVS drug is approved for complement 3 glomerulopathy (C3G) and PNH indications.
AZN’s COPD Drug Secures Win in Third Late-Stage Study
In a separate press release, AstraZeneca announced that its experimental monoclonal antibody, tozorakimab, met the primary endpoint in the phase III MIRANDA study for chronic obstructive pulmonary disease ("COPD").
The study achieved its primary endpoint — the drug demonstrated a statistically significant and clinically meaningful reduction in the annualized rate of moderate-to-severe COPD exacerbations (or worsening of disease symptoms) compared with placebo. These findings are consistent with results from the phase III OBERON and TITANIA studies reported last month, both of which also met their primary endpoints.
The results highlight tozorakimab’s potential for a chronic condition like COPD, which remains the third leading cause of death globally, with approximately 400 million patients worldwide and limited treatment options. The drug targets IL-33, a key driver of inflammation. Rival treatments targeting this pathway, such as Sanofi (SNY - Free Report) /Regeneron’s itepekimab and Roche’s astegolimab, have previously reported mixed or unsuccessful late-stage study results last year, emphasizing the significance of AstraZeneca’s data.
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AstraZeneca's Ultomiris Meets Goal in Rare Kidney Disease Study
Key Takeaways
AstraZeneca (AZN - Free Report) announced positive results from an interim analysis of the ongoing late-stage I CAN study, which evaluated its blockbuster rare disease drug Ultomiris (ravulizumab) for IgA nephropathy (IgAN), a rare progressive kidney disease.
At the interim analysis, the study met its first primary endpoint. Treatment with Ultomiris for 34 weeks led to a statistically significant and clinically meaningful reduction in proteinuria (protein in urine), with effects observed as early as week 10.
While AstraZeneca did not disclose numerical data, it plans to share the results with regulatory authorities to pursue accelerated approval across key markets. The I CAN study will continue toward completion, with the second primary endpoint — change in estimated glomerular filtration rate (eGFR) — to be evaluated at week 106.
Ultomiris is currently approved in the United States, Europe and Japan across four indications. These include atypical haemolytic uraemic syndrome (aHUS), generalized myasthenia gravis (gMG), neuromyelitis optica spectrum disorder ("NMOSD") and paroxysmal nocturnal haemoglobinuria ("PNH").
The drug has become a key driver of growth for the company. In 2025, Ultomiris generated $4.72 billion in sales, up 20% year over year, driven by strong demand across approved indications, geographic expansion and continued patient conversion from Soliris.
AZN Stock Performance
The stock outperformed the industry in the year-to-date period, as seen in the chart below.
Image Source: Zacks Investment Research
Other Players in the IgAN Space
If approved, Ultomiris will likely compete with the likes of Calliditas Therapeutics’ Tarpeyo, Novartis’ (NVS - Free Report) Fabhalta and Travere Therapeutics’ (TVTX - Free Report) Filspari.
Both Calliditas’ Tarpeyo and Travere’s Filspari are approved for a similar indication — to slow the decline in kidney function in adults with primary IgAN who are at risk of disease progression.
Novartis’ Fabhalta is approved under the accelerated pathway for reducing proteinuria in adults with primary IgAN at risk of rapid disease progression. The NVS drug is approved for complement 3 glomerulopathy (C3G) and PNH indications.
AZN’s COPD Drug Secures Win in Third Late-Stage Study
In a separate press release, AstraZeneca announced that its experimental monoclonal antibody, tozorakimab, met the primary endpoint in the phase III MIRANDA study for chronic obstructive pulmonary disease ("COPD").
The study achieved its primary endpoint — the drug demonstrated a statistically significant and clinically meaningful reduction in the annualized rate of moderate-to-severe COPD exacerbations (or worsening of disease symptoms) compared with placebo. These findings are consistent with results from the phase III OBERON and TITANIA studies reported last month, both of which also met their primary endpoints.
The results highlight tozorakimab’s potential for a chronic condition like COPD, which remains the third leading cause of death globally, with approximately 400 million patients worldwide and limited treatment options. The drug targets IL-33, a key driver of inflammation. Rival treatments targeting this pathway, such as Sanofi (SNY - Free Report) /Regeneron’s itepekimab and Roche’s astegolimab, have previously reported mixed or unsuccessful late-stage study results last year, emphasizing the significance of AstraZeneca’s data.
AstraZeneca PLC Price
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AZN’s Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.